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Re: kevindenver post# 124023

Wednesday, 10/11/2017 3:02:56 PM

Wednesday, October 11, 2017 3:02:56 PM

Post# of 517710
Yea, the Good Results Were Phony (?)

Sample size of prior trials...



So, Anavex didn’t test their drug on enough Alzheimer’s patients to determine to any degree if it worked?

Of course, for FDA authorization, the big Phase 3 study will have to be conducted, and favorable outcomes precisely documented. Statistical analysis. FDA doesn’t much approve drugs on the basis of stock investor perceptions.

Potential or current Anavex investors can presently see the matter in at least two ways.

Some, based upon the principles of biostatistics, solely, contend that there can be no way of knowing any useful safety or efficacy in the Phase 1 trial of just 25 to 31 Alzheimer’s patients. “Sample size” too small. Who could (would, or should) determine anything from those results?

Others, take cognizance of the facts that a) symptoms in all participants were either held at baseline (didn’t decline), or actually improved, and b) no other approved drug has shown these traits. Those holding to this view perceive that the chances of randomly including only 100% super responders as the cause of the good results are minute; that the real reason all trial participants maintained or improved their cognition was because Anavex 2-73, with its unique mechanism of action, actually does, as the company contends, restores neuron homeostasis, normalized nerve function.

This post is not intended to change or modify anyone’s personal perception of the matter. Merely, it’s posted for an interesting analysis of the eventual Phase 3 results.

Who will prove to have had it right from the start? The “No can tell, too small – stay out early” crowd? Or, the “Can’t be anything but good –- get in early” crowd?
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